Botanical formulations

ABSTRACT

Disclosed is a method for treating skin. The method can include topically applying to skin in need thereof a composition comprising effective amounts of Arctium lappa root extract and Epilobium angustifolium extract to reduce expression of a pro-inflammatory cytokine of IL-8, IL-2, or TNF-α in the skin.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/388,541, filed Dec. 22, 2016, which is a continuation of U.S.application Ser. No. 14/266,382 filed Apr. 30, 2014, now U.S. Pat. No.9,561,198, which is a continuation of U.S. application Ser. No.13/907,500 filed May 31, 2013, now U.S. Pat. No. 8,747,926, which is acontinuation of U.S. application Ser. No. 13/326,138 filed Dec. 14,2011, now U.S. Pat. No. 8,481,090, which is a continuation of U.S.application Ser. No. 12/768,450 filed Apr. 27, 2010, now U.S. Pat. No.8,440,237, which claims the benefit of U.S. Provisional Application No.61/173,042, filed Apr. 27, 2009. The contents of the referencedapplications are incorporated herein by reference.

BACKGROUND OF THE INVENTION A. Field of the Invention

The present invention relates generally to compositions that includebotanical extracts that can be used to reduce the redness associatedwith acne lesions, improve skin clarity through dermal remodeling, andprotect the skin from additional acne breakouts. The compositions of thepresent invention can also be used to treat or prevent a wide variety ofskin conditions. In particular, the present invention concerns topicalskin care compositions that include Arctium lappa (Burdock) rootextract, Epilobium angustifolium (Canadian Willowherb) extract, Pinussylvestris bark extract, Ribes nigrum (Black Currant) leaf extract,Peumus boldus (Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet)extract, Cystoseira amentacea/Caespitosa Brachycarpa extract, Hydrolyzedsoy protein, Navy bean extract, or Mushroom extract, or any combinationthereof. In particular aspects, the composition includes a combinationof Epilobium angustifolium (Canadian Willowherb) extract, Arctium lappa(Burdock) root extract, and Cystoseira amentacea/Caespitosa Brachycarpaextract.

B. Description of Related Art

Salicylic acid, benzoic acid, benzoyl peroxide, and tretinoin are knownanti-acne ingredients. Problems/side effects associated with theseingredients include dry skin, scaly skin, and flaky skin. They can alsoirritate the skin, which causes the skin to appear red and feel like itis burning. Such irritation adds to the already painful sensationassociated with the presence of acne on the skin.

SUMMARY OF THE INVENTION

The present invention overcomes deficiencies in the art by providinganti-acne compositions that can treat, reduce, or prevent the appearanceof the signs of acne on skin (e.g., comedones, papules, pustules,nodulocystic lesions, skin redness, etc.). These compositions caninclude Arctium lappa (Burdock) root extract, Epilobium angustifolium(Canadian Willowherb) extract, Pinus sylvestris bark extract, Ribesnigrum (Black Currant) leaf extract, Peumus boldus (Boldo) leaf extract,Spiraea ulmaria (Meadow Sweet) extract, Cystoseira amentacea/CaespitosaBrachycarpa extract, Hydrolyzed soy protein, Navy bean extract, orMushroom extract, or any combination thereof. In particular aspects, thecomposition includes a combination of Epilobium angustifolium (CanadianWillowherb) extract, Arctium lappa (Burdock) root extract, andCystoseira amentacea/Caespitosa Brachycarpa extract. In other aspects,the combination of ingredients can be Ribes nigrum (Black curant) leafextract, Cystoseira amentacea/Caespitosa Brachycarpa extract, hydrolyzedsoy protein, Epilobium angustifolium (Canadian Willowherb) extract, andArctium lappa (Burdock) root extract. In even a more particular aspect,the combination of ingredients can be Ribes nigrum (Black curant) leafextract, Cystoseira amentacea/Caespitosa Brachycarpa extract, hydrolyzedsoy protein, Epilobium angustifolium (Canadian Willowherb) extract,Arctium lappa (Burdock) root extract, navy bean extract, and mushroomextract.

The compositions can also include an added benefit of reducing orpreventing the appearance of dry, scaly, flaky skin and skin irritation.That is, the compositions of the present invention can reduce, prevent,or treat the signs of acne on skin while also reducing or preventing oravoiding side-effects such as dry, scaly, flaky skin and skinirritation. These side-effects can be reduced or prevented or avoidedeven if anti-acne ingredients that are known to cause such side-effects(e.g., salicylic acid, benzoic acid, benzoyl peroxide, tretinoin, etc.)are incorporated into the compositions of the present invention ateffective amounts.

As noted above, the compositions of the present invention can includeArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, Pinus sylvestris bark extract, Ribes nigrum (BlackCurrant) leaf extract, Peumus boldus (Boldo) leaf extract, Spiraeaulmaria (Meadow Sweet) extract, Cystoseira amentacea/CaespitosaBrachycarpa extract, Soy extract, Navy bean extract, or Mushroomextract, or any one of, any combination of, or all of such ingredients.Further, as shown in the figures and examples (which are incorporatedinto this section by reference), the inventors have discovered that thecombination of Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, and Cystoseiraamentacea/Caespitosa Brachycarpa extract produce synergistic andcomplimentary effects that are beneficial to skin and to treating orpreventing acne. The compositions can also include other anti-acneingredients, even those known to cause undesirable side-effects such asdry, flaky, scaly skin or skin irritation (e.g., salicylic acid, benzoicacid, benzoyl peroxide, tretinoin etc.).

In certain embodiments, the compositions are formulated into topicalskin care compositions. The compositions can be cosmetic compositions.In other aspects, the compositions can be included in a cosmeticvehicle. Non-limiting examples of cosmetic vehicles are disclosed inother sections of this specification and are known to those of skill inthe art. Examples of cosmetic vehicles include emulsions (e.g.,oil-in-water and water-in-oil emulsions), creams, lotions, solutions(e.g., aqueous or hydro-alcoholic solutions), anhydrous bases (e.g.,lipstick or a powder), gels, and ointments. In other non-limitingembodiments, the compositions of the present invention can be includedin anti-aging, cleansing, or moisturizing products. The compositions canalso be formulated for topical skin application at least 1, 2, 3, 4, 5,6, 7, or more times a day during use. In other aspects of the presentinvention, compositions can be storage stable or color stable, or both.It is also contemplated that the viscosity of the composition can beselected to achieve a desired result (e.g., depending on the type ofcomposition desired, the viscosity of such composition can be from about1 cps to well over 1 million cps or any range or integer derivabletherein (e.g., 2 cps, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70,80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000,4000, 5000, 6000, 7000, 8000, 9000, 10000, 20000, 30000, 40000, 50000,60000, 70000, 80000, 90000, 100000, 200000, 300000, 400000, 500000,600000, 700000, 800000, 900000, 1000000 cps, etc., as measured on aBrookfield Viscometer using a TC spindle at 2.5 rpm at 25° C.). Thecompositions in non-limiting aspects can have a pH of about 6 to about9. In other aspects, the pH can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, or 14. In other aspects, the compositions can be sunscreenshaving a sun protection factor (SPF) of 1, 5, 10, 15, 20, 25, 30, 35,40, 45, 50, 55, or more.

In particular aspects, the compositions can be oil-free, substantiallyanhydrous, and/or anhydrous. Other aspects include compositions havingwater.

The compositions of the present invention can include from about 0.001%to about 50%, by weight, of Arctium lappa (Burdock) root extract,Epilobium angustifolium (Canadian Willowherb) extract, Pinus sylvestrisbark extract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, Hydrolyzed soy protein, Navybean extract, or Mushroom extract, or any combination thereof. It shouldbe recognized, however, that the amount of such ingredients within acomposition can be modified below, within, or above this range based onthe desired results. Therefore, the amount of such ingredients caninclude less than 0.0001%. In other aspects, the compositions caninclude 0.0001, 0.0002 . . . 0.002, 0.003, 0.004 . . . 1, 2, 3, 4, 5, 6,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45,50, 60, 70, 80, 90, 95, 96, 97, 98, 99%, or more or, or any rangederivable therein, by weight or volume of Arctium lappa (Burdock) rootextract, Epilobium angustifolium (Canadian Willowherb) extract, Pinussylvestris bark extract, Ribes nigrum (Black Currant) leaf extract,Peumus boldus (Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet)extract, Cystoseira amentacea/Caespitosa Brachycarpa extract, Hydrolyzedsoy protein, Navy bean extract, or Mushroom extract, or any combinationthereof. In certain aspects, the composition can include adermatologically acceptable vehicle or carrier. Such vehicle or carriercan include any one of, any combination of, or all of the followingingredients: water; salicylic acid or benzoyl peroxide or a combinationthereof; phenoxyethanol; butylene glycol; citric acid; propylene glycol;methylparaben or propylparaben or a combination thereof; glycerin;chlorphenesin; and/or sodium metabisulfite.

The compositions of the present invention can also be modified to have adesired oxygen radical absorbance capacity (ORAC) value. In certainnon-limiting aspects, the compositions of the present invention can bemodified to have an ORAC value per mg of at least about 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24,25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 95, 100,200, 300, 400, 500, 600, 700, 800, 900, 1000, 2000, 3000, 4000, 5000,6000, 7000, 8000, 9000, 10000, 15000, 20000, 30000, 50000, 100000 ormore or any range derivable therein.

In other non-limiting aspects of the present invention, the compositionscan further include a vitamin, a mineral, an essential fatty acid, anamino acid, a flavonoid, and/or a protein, or a combination thereof.Non-limiting examples of vitamins include the B vitamins (e.g., B1, B2,B6, B12, niacin, folic acid, biotin, and pantothenic acid), vitamin C,vitamin D, vitamin E (e.g., tocopherol or tocopheryl acetate), vitamin A(e.g., palmitate, retinyl palmitate, or retinoic acid), and vitamin K.Non-limiting examples of minerals include iron, potassium, phosphorus,magnesium, manganese, selenium, and calcium. Non-limiting examples ofessential fatty acids include Omega 3 (linolenic acid), Omega 6(linoleic acid) and Omega 9 (oleic acid) essential fatty acid, or acombination thereof. Non-limiting examples of amino acids includeessential amino acids (e.g., lysine, leucine, isoleucine, methionine,phenylalanine, threonine, tryptophan, valine, histidine, or arginine)and non-essential amino acids (e.g., serine, asparagine, glutamine,aspartic acid, glutamic acid, alanine, tyrosine, cysteine, glycine, orproline). Non-limiting examples of flavonoids include anthocyanincompounds (e.g., cyanidin-3-glucoside and cyanidin-3-rutinoside).

The compositions can include a triglyceride, a preservative, anessential oil, a UV absorption ingredient, and/or additional ingredientsdescribed in the specification and known in the art, and any combinationthereof. Non-limiting examples of triglycerides include small, medium,and large chain triglycerides. Non-limiting examples of preservativesinclude methylparaben, propylparaben, or a mixture of methylparaben andpropylparaben. Non-limiting examples of essential oils are thosedescribed in the specification and those known to a person of ordinaryskill in the art. Examples include sesame oil, macadamia nut oil, teatree oil, evening primrose oil, Spanish sage oil, Spanish rosemary oil,Coriander oil, Thyme oil, or Pimento berries oil. Non limiting examplesof UV absorption ingredients include dibenzoylmethane derivatives (e.g.,avobenzone), octocrylene, oxybenzone, homosalate, octisalate, octylmethoxycinnamate, ecamsule, titanium dioxide, zinc oxide, etc., andothers described in the specification and known to those in the art, andany combination thereof.

Also disclosed is a method of treating or preventing a skin conditioncomprising topical application of a composition comprising Arctium lappa(Burdock) root extract, Epilobium angustifolium (Canadian Willowherb)extract, Pinus sylvestris bark extract, Ribes nigrum (Black Currant)leaf extract, Peumus boldus (Boldo) leaf extract, Spiraea ulmaria(Meadow Sweet) extract, Cystoseira amentacea/Caespitosa Brachycarpaextract, Hydrolyzed soy protein, Navy bean extract, or Mushroom extract,or any combination thereof, wherein the topical application of thecomposition treats the skin condition. The method can include topicalapplication of the composition to a portion of skin in need of suchcomposition (e.g., skin having a skin condition), wherein topicalapplication reduces or prevents the skin condition when compared to skinthat has a skin condition and that has not been treated with thecomposition. Non-limiting examples of skin conditions include acne,symptoms associated with acne (e.g., presence of open or closedcomedones, papules, pustules, nodulocystic lesions, skin redness, etc.),pruritus, spider veins, lentigo, age spots, senile purpura, keratosis,melasma, blotches, fine lines or wrinkles, nodules, sun damaged skin,dermatitis (including, but not limited to seborrheic dermatitis,nummular dermatitis, contact dermatitis, atopic dermatitis, exfoliativedermatitis, perioral dermatitis, and stasis dermatitis), psoriasis,folliculitis, rosacea, impetigo, erysipelas, erythrasma, eczema, andother inflammatory skin conditions. In certain non-limiting aspects, theskin condition can be caused by exposure to UV light, age, irradiation,chronic sun exposure, environmental pollutants, air pollution, wind,cold, heat, chemicals, disease pathologies, smoking, or lack ofnutrition. The skin can be facial skin or non-facial skin (e.g., arms,legs, hands, chest, back, feet, etc.). The method can further compriseidentifying a person in need of skin treatment. The person can be a maleor female. The age of the person can be at least 1, 2, 3, 4, 5, 6, 7, 8,9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90,95, or more years old, or any range derivable therein. The method canalso include topically applying an amount effective to: increase thestratum corneum turnover rate of the skin; increase collagen synthesisin fibroblasts; increase cellular anti-oxidant defense mechanisms (e.g.,exogenous additions of anti-oxidants can bolster, replenish, or preventthe loss of cellular antioxidants such as catalase and glutathione inskin cells (e.g., keratinocytes, melanocytes, langerhans cells, etc.)which will reduce or prevent oxidative damage to the skin, cellular,proteins, and lipids); inhibit melanin production in melanocytes; reduceor prevent oxidative damage to skin (including reducing the amount lipidperoxides and/or protein oxidation in the skin).

In certain embodiments, compositions of the present invention candecrease the amount of internal oxidation and/or external oxidativedamage in a cell. In other aspects, the compositions can increasecollagen synthesis in a cell. The compositions can also reduce skininflammation, such as by reducing inflammatory cytokine production in acell. Non-limiting examples of such cells include human epidermalkeratinocyte, human fibroblast dermal cell, human melanocytes, threedimensional human cell-derived in vitro tissue equivalents comprisinghuman keratinocytes, human fibroblasts, or human melanocytes, or anycombination thereof (e.g., combination of human keratinocytes and humanfibroblasts or a combination of human keratinocytes and humanmelanocytes).

Also disclosed is a method of reducing side-effects associated withtopical application of anti-acne agents to skin. The method can includeincorporating botanical extracts selected from the group consisting ofArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, Pinus sylvestris bark extract, Ribes nigrum (BlackCurrant) leaf extract, Peumus boldus (Boldo) leaf extract, Spiraeaulmaria (Meadow Sweet) extract, Cystoseira amentacea/CaespitosaBrachycarpa extract, Hydrolyzed soy protein, Navy bean extract, orMushroom extract, or any combination thereof, into a topical anti-acneformulation which includes an anti-acne agent known to causeside-effects, wherein the addition of the botanical extract into thecomposition reduces or prevents the side-effects to the skin. Theanti-acne agent can be salicylic acid, benzoic acid, benzoyl peroxide,tretinoin, etc. The side-effect can be dry skin, scaly skin, flaky skin,or skin irritation.

In yet another embodiment, the compositions of the present invention canalso be used to reduce side-effects associated with topical applicationof a pharmaceutical ingredient to skin. The method can includeincorporating botanical extracts selected from the group consisting ofArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, Pinus sylvestris bark extract, Ribes nigrum (BlackCurrant) leaf extract, Peumus boldus (Boldo) leaf extract, Spiraeaulmaria (Meadow Sweet) extract, Cystoseira amentacea/CaespitosaBrachycarpa extract, Hydrolyzed soy protein, Navy bean extract, orMushroom extract, or any combination thereof, or at least 1, 2, 3, 4, 5,6, 7, 8, 9, or all 10 of the aforementioned ingredients, into a topicalskin formulation which includes a pharmaceutical ingredient known tocause side-effects, wherein the addition of the botanical extract intothe composition reduces or prevents the side-effects to the skin. Inparticular aspects, the composition includes Arctium lappa (Burdock)root extract, Epilobium angustifolium (Canadian Willowherb) extract, andCystoseira amentacea/Caespitosa Brachycarpa extract.

The pharmaceutical ingredient can be an ingredient selected from thegroup consisting of agents used to treat rosacea, analgesics,anesthetics, anorectals, antihistamines, anti-inflammatory agentsincluding non-steroidal anti-inflammatory drugs, antibiotics,antifungals, antivirals, antimicrobials, anti-cancer actives,scabicides, pediculicides, antineoplastics, antiperspirants,antipruritics, antipsoriatic agents, anti seborrheic agents,biologically active proteins and peptides, burn treatment agents,cauterizing agents, depigmenting agents, depilatories, diaper rashtreatment agents, enzymes, hair growth stimulants, hair growthretardants including DFMO and its salts and analogs, hemostatics,kerotolytics, canker sore treatment agents, cold sore treatment agents,dental and periodontal treatment agents, photosensitizing actives, skinprotectant/barrier agents, steroids including hormones andcorticosteroids, sunburn treatment agents, sunscreens, transdermalactives, nasal actives, vaginal actives, wart treatment agents, woundtreatment agents, or wound healing agents.

Also disclosed is a method of lightening skin or evening skin tonecomprising applying the compositions of the present invention to theskin. The method can further comprise identify a person in need oflightening skin or evening skin tone. The methods can further includeinhibiting melanogenesis in a skin cell, inhibiting tyrosinase ortyrosinase synthesis in a skin cell, or inhibiting melanin transport tokeratinocytes in a skin cell. The composition can act as an alphamelanin stimulatory hormone antagonist. The composition can even outpigmentation of the skin. In non-limiting aspect, lightening skin caninclude reducing the appearance of an age spot, a skin discoloration, ora freckle by topical application of the composition to skin having anage spot, skin discoloration, a freckle, etc.

Also disclosed is a method of treating hyperpigmentation comprisingapplying the compositions of the present invention to the skin. Themethod can also comprise identifying a person in need of treatinghyperpigmentation. Additional methods contemplated by the inventorinclude methods for reducing the appearance of an age spot, a skindiscoloration, or a freckle, reducing or preventing the appearance offine lines or wrinkles in skin, or increasing the firmness of skin.

Also disclosed is a method of treating erythema or reducing theappearance of symptoms associated with erythema, sensitive skin, orinflamed skin, comprising topically to erythemic, sensitive, or inflamedskin any one of the compositions of disclosed throughout thisspecification. In particular embodiments, the composition can includeArctium lappa root extract, Epilobium angustifolium extract, orCystoseira amentacea/Caespitosa Brachycarpa extract or any combinationthereof. In particular instances, the erythema can be caused by acne oran acne lesion (e.g., a comedone, a papule, a pustule, or a nodulocysticlesion on the skin). In other instances, the erythema can be caused byskin sunburn, electrical treatments of skin, skin burns, contactallergies, systemic allergies, skin toxicity, exercise, insect stings,bacterial infection, viral infection, fungal infection, protozoainfection, massage, or windburn.

Compositions comprising Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, Pinus sylvestris barkextract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, Hydrolyzed soy protein, Navybean extract, or Mushroom extract, or any combination thereof, canproduce synergistic effects. For example, such ingredients can worktogether synergistically to produce effects that exceed the effects ofwhat would be expected if the extracts were used in separatecompositions. Non-limiting synergistic effects include treating orpreventing acne and symptoms associated with the same, while alsopreventing, reducing, or avoiding side-effects such as dry, flaky, scalyskin or skin irritation.

Compositions comprising Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, Pinus sylvestris barkextract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, Hydrolyzed soy protein, Navybean extract, or Mushroom extract, or any combination thereof, can alsoact in a complementary fashion. For example, such ingredients can beused to treat or prevent acne, treat, prevent, or reduce the appearanceof the signs of acne on skin, and reduce, prevent, avoid skin dryness,scaliness, flakiness, or skin irritation, and vice-versa.

Also contemplated are kits that includes the compositions of the presentinvention. In certain embodiments, the composition is comprised in acontainer. The container can be a bottle, dispenser, or package. Thecontainer can dispense a pre-determined amount of the composition. Incertain aspects, the compositions is dispensed in a spray, dollop, orliquid. The container can include indicia on its surface. The indiciacan be a word, an abbreviation, a picture, or a symbol.

Also contemplated is a product comprising a composition of the presentinvention. In non-limiting aspects, the product can be a cosmeticproduct. The cosmetic product can be those described in other sectionsof this specification or those known to a person of skill in the art.Non-limiting examples of products include a moisturizer, a cream, alotion, a skin softener, a foundation, a night cream, a lipstick, acleanser, a toner, a sunscreen, a mask, or an anti-aging product.

It is also contemplated that compositions of the present invention canbe included into food-based products (e.g., beverages, fortified water,energy drinks, nutritional drinks, solid foods, vitamins, supplements,etc.) and pharmaceutical products (e.g., pills, injectible solutions,drugs, etc.). “Supplements” can include vitamins, minerals, herbs orother botanicals, amino acids, enzymes and metabolites. Such supplementsare suitable for oral consumption and can be administered orally.

The compositions and methods for their use can “comprise,” “consistessentially of,” or “consist of” any of the ingredients disclosedthroughout the specification.

It is contemplated that any embodiment discussed in this specificationcan be implemented with respect to any method or composition of theinvention, and vice versa. Furthermore, compositions of the inventioncan be used to achieve methods of the invention.

In one embodiment, compositions of the present invention can bepharmaceutically or cosmetically elegant. “Pharmaceutically elegant”and/or “cosmetically elegant” describes a composition that hasparticular tactile properties which feel pleasant on the skin (e.g.,compositions that are not too watery or greasy, compositions that have asilky texture, compositions that are non-tacky or sticky, etc.).Pharmaceutically or cosmetically elegant can also relate to thecreaminess or lubricity properties of the composition or to the moistureretaining properties of the composition.

“Topical application” means to apply or spread a composition onto thesurface of keratinous tissue. “Topical skin composition” includescompositions suitable for topical application on keratinous tissue. Suchcompositions are typically dermatologically-acceptable in that they donot have undue toxicity, incompatibility, instability, allergicresponse, and the like, when applied to skin. Topical skin carecompositions of the present invention can have a selected viscosity toavoid significant dripping or pooling after application to skin.

“Keratinous tissue” includes keratin-containing layers disposed as theoutermost protective covering of mammals and includes, but is notlimited to, skin, hair and nails.

A “non-volatile oil” includes those substance that will not evaporate atordinary or room temperature.

The terms “mixture,” “mix,” and “mixing” or any variants of these terms,when used in the claims and/or specification includes, stirring,blending, dispersing, milling, homogenizing, and other similar methods.The mixing of the components or ingredients of the disclosedcompositions can form into a solution. In other embodiments, themixtures may not form a solution. The ingredients/components can alsoexist as undissolved colloidal suspensions.

The term “about” or “approximately” are defined as being close to asunderstood by one of ordinary skill in the art, and in one non-limitingembodiment the terms are defined to be within 10%, preferably within 5%,more preferably within 1%, and most preferably within 0.5%.

The term “substantially” and its variations are defined as being largelybut not necessarily wholly what is specified as understood by one ofordinary skill in the art, and in one non-limiting embodimentsubstantially refers to ranges within 10%, within 5%, within 1%, orwithin 0.5%.

The terms “inhibiting” or “reducing” or “preventing” or “avoiding” orany variation of these terms, when used in the claims and/or thespecification includes any measurable decrease or complete inhibition toachieve a desired result.

The term “effective,” as that term is used in the specification and/orclaims, means adequate to accomplish a desired, expected, or intendedresult.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more,” “at least one,”and “one or more than one.”

The use of the term “or” in the claims is used to mean “and/or” unlessexplicitly indicated to refer to alternatives only or the alternativesare mutually exclusive, although the disclosure supports a definitionthat refers to only alternatives and “and/or.”

As used in this specification and claim(s), the words “comprising” (andany form of comprising, such as “comprise” and “comprises”), “having”(and any form of having, such as “have” and “has”), “including” (and anyform of including, such as “includes” and “include”) or “containing”(and any form of containing, such as “contains” and “contain”) areinclusive or open-ended and do not exclude additional, unrecitedelements or method steps.

Other objects, features and advantages of the present invention willbecome apparent from the following detailed description. It should beunderstood, however, that the detailed description and the examples,while indicating specific embodiments of the invention, are given by wayof illustration only. Additionally, it is contemplated that changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings form part of the present specification and areincluded to further demonstrate certain aspects of the presentinvention. The invention may be better understood by reference to one ormore of these drawings in combination with the detailed description ofspecific embodiments presented below.

FIG. 1 Arctium lappa (Burdock) root extract, Epilobium angustifolium(Canadian Willowherb) extract, and Cystoseira amentacea/CaespitosaBrachycarpa extract, reduce the expression of proinflamattory cytokinesIL-8, IL-2, and TNF-α in human epidermal keratinocytes.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Acne is commonly referred to as a disorder of the pilosebaceuous unit,which includes the hair follicle, seabaceous gland, and sebaceous duct.Propionibacterium acnes (“P. acnes”), an anaerobic bacteria, is presentin all types of human skin and is part of the skin's natural sebummaintenance system.

Sebaceous glands produce sebum, which is excreted through the sebaceousduct and travels up the follicle. The sebum mixes with common skinbacteria (including P. acnes) and dead skin cells that have been shedfrom the lining of the follicle. While this process is normal, thepresence of extra sebum (note that sebum production can increase whenstimulated by hormones such as androgens) can increase the possibilitythat the pilosebaceuous unit becomes plugged/clogged/obstructed. The endresult of this is oftentimes an inflammatory response, which can lead topimples becoming red, swollen, and painful.

The outward signs of acne on the skin has been categorized asnoninflammatory and inflammatory acne. Noninflammatory acne typicallyincludes the presence of whiteheads and blackheads (respectivelyreferred to as closed and open comedones). These comedones are compactmasses of keratin, sebum, and bacteria, which dilate the follicularduct. A comedone forms when a follicle or sebaceous duct isplugged/clogged/obstructed. Inflammatory acne has been characterized bypapules (pimples), pustules, and nodulocystic lesions which can lead toscarring of the skin.

The compositions of the present invention provide for an effectiveoption for treating, reducing, or preventing acne and its associatedsymptoms (e.g., presence of open and closed comedones, papules,pustules, nodulocystic lesions, skin redness, etc.) by providing topicalskin compositions which include natural botanical extracts such asArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, Pinus sylvestris bark extract, Ribes nigrum (BlackCurrant) leaf extract, Peumus boldus (Boldo) leaf extract, Spiraeaulmaria (Meadow Sweet) extract, Cystoseira amentacea/CaespitosaBrachycarpa extract, Hydrolyzed soy protein, Navy bean extract, orMushroom extract, or any combination thereof. The compositions of thepresent invention also provide a solution to the above-describedproblems associated with popular anti-acne agents such as salicylicacid, benzoic acid, benzoyl peroxide, and tretinoin. These types ofcaustic anti-acne agents can be incorporated into compositions of thepresent invention at effective amounts while avoiding or substantiallyreducing the unwanted side-effects. Another advantage is that higherlevels of such caustic anti-acne agents can be used, thereby increasingthe composition's overall anti-acne effectiveness and the unsightlysymptom associated with skin acne.

A. Botanical Anti-Acne Ingredients

As explained above, topical skin compositions of the present inventioncan include Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, Pinus sylvestris barkextract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, Hydrolyzed soy protein, Navybean extract, or Mushroom extract, or any combination thereof. Theseingredients can be obtained from third party sellers. For instance,Arctium lappa (Burdock) root extract, extract obtained from the root ofburdock, can be purchased from C&F Koei Phyto Corp. (USA) under thetrades name BURDOCK ROOT EXTRACT™, ORGANIC BURDOCK EXTRACT BG-50™, fromIndena SA (Spain) under the trade name PHYTELENE OF BURDOCK-ROOTS EN422™, or from Greentech S.A. (France) under the trade names PHYTELENECOMPLEX EGX 232™ PHYTELENE COMPLEX EGX247™, PHYTELENE COMPLEX EGX 252™,PHYTELENE OF BARDANE EG 195 LIQUID™, PHYTELENE OF BURDOCK EG 195LIQUID™.

Epilobium angustifolium (Canadian Willowherb) extract obtained from theflower, leaf, and stem can be purchased from Atrium Innovations (France)under the trade names CANADIAN WILLOWHERB EXTRACT™ (5% clear), CANADIANWILLOWHERB EXTRACT™ (5% in water), CANADIAN WILLOWHERB EXTRACT-10%™ (inglycerin), from Fytokem (Canada) under the trade names CANADIANWILLOWHERB EXTRACT™ (5% clear), CANADIAN WILLOWHERB EXTRACT™ (5% inwater), CANADIAN WILLOWHERB EXTRACT-10%™ (in glycerin), or fromGreentech S.A. (France) under the trade names ARP 100 HUILEUX™, andSEBORILYS™. Epilobium angustifolium (Canadian Willowherb) extractobtained from the leaf can be purchased from Cosmetochem International(Germany) under the trade name HERBASEC ROSE BAY WILLOW-HERB™.

Pinus sylvestris bark extract, extract of the bark of Pinus sylvestris,can be purchased from Greentech S.A. (France) under the trade nameEPICA™.

Ribes nigrum (Black Currant) leaf extract, extract from the leaf ofBlack Currant, can be purchased from Greentech S.A. (France) under thetrade name EPICA™, from Alban Muller International (France) under thetrade names BLACKCURRANT LEAF HPG TITRATED™, BLACKCURRANT LEAF HS™, andPHYTAMI of ORGANIC BLACKCURRANT™, and from Solabia Group (France) underthe trade names AE COMPLEX BG™ and AE COMPLEX GLYCERIN™.

Peumus boldus (Boldo) leaf extract, extract from the leaves of Boldo,can be purchased from Bio-Botanica (USA) under the trade name BOLDOPOWDERED EXTRACT™, from Phytocos (France) under the trade names AROMEBOLDO™, EXTRAIT DE BOLDO LP1™, and EXTRAIT DE BOLDO SGLP™, or from Silab(France) under the trade names SCULPTURINE™ and SLIMACTIVE™.

Spiraea ulmaria (Meadow Sweet) extract obtained from the leaf can bepurchased from Gattefosse (Canada) under the trade name CYTOBIOULMAIRE™. Spiraea ulmaria extract obtained from the whole plant can bepurchased from Active Concepts (USA) under the trade name ACBMEADOWSWEET EXTRACT™, ACB MEADOWSWEET EXTRACT 20%™, from Silab (France)under the trade names DERMAPUR™, SEBONORMINE™, and SEBOREGUL™, or fromPhytocos (France) under the trade names COMPLEXE AMINCISSANT LP1™,COMPLEXE AMINCISSANT SGLP™, EXTRAIT d'ULMAIRE LP1™, and EXTRAITd'ULMAIRE SGLP™. Spiraea ulmaria extract obtained from the flower can bepurchased from Indena S.A. (France) under the trade name SWEETSUPEXTRAT™ or from Greentech S.A. (France) under the trade namesPHYTELENE COMPLEX EGX 250™, PHYTELENE OF QUEEN MEADOW EG 213 LIQUID™,and PHYTELENE OF ULMAIRE EG 213 LIQUID™, and SLIMMING™. Spiraea ulmariaextract obtained from the root can purchased from Active Organics (USA)under the trade names ACTIPHYTE OF MEADOWSWEET PG50™, CO ACTIPHYTE OFMEADOWSWEET AJ™, CO ACTIPHYTE OF MEADOWSWEET AL™, CO ACTIPHYTE OFMEADOWSWEET GL™, CO ACTIPHYTE OF MEADOWSWEET LIPO O™, CO ACTIPHYTE OFMEADOWSWEET LIPO RS™, CO ACTIPHYTE OF MEADOWSWEET LIPO S™, and COACTIPHYTE OF MEADOWSWEET LIPO SUN™.

Cystoseira amentacea/Caespitosa Brachycarpa extract, a water fractionprepared from Cystoseira amentacea Bory, Cystoseira caespitosaSauvageau, and Cystoseira brachycarpa var. balearica (Sauvageau)Giaccone, can be purchased from Gelyma (France) or Biosil Technologies(USA) under the trade name SEA HEATHER™.

Hydrolyzed soy protein, which is hydrolysate of soy protein derived byacid, enzyme, or other methods of hydrolysis, can be purchased from MGPIngredients Inc. (USA) under the trade name AQUA PRO™ SP, AQUA PRO™ SP15, AQUA PRO™ SP 20, and AQUA PRO™ SPSF, or from Arch Personal CareProducts (USA) under the trade names SOLU-SOY™ 25, SOLU-SOY™ EN-25,SOLU-SOY™ ENSD, or SOLU-SOY™ 25, or from Croda, Inc. (USA) under thetrade names HYDROSOY2000™ or HYDROSOY 2000 SF POWDER™, or from ActiveConcepts (USA) under the trade names AC SOY HYDROLYSATE™ or AC SOYHYDROLYSATE 30™.

Navy bean extract (also referred to as white bean extract), extractobtained from the navy bean—a small white kidney bean—can be purchasedfrom InfraReady Products, Ltd. (Canada), under the trade name PRE-COOKEDNAVY BEAN POWDER™.

Mushroom extract, extract obtained from mushrooms, can be purchased fromActive Concepts (USA), under the trade names ACB MUSHROOM EXTRACT(POWDER) SM™, ACB MUSHROOM EXTRACT SM™, ACB SONGYI MUSHROOM EXTRACT™,ACB SONGYI MUSHROOM EXTRACT POWDER™, ABS MUSHROOM EXTRACT BG, or ABSMUSHROOM EXTRACT POWDER™.

Additional information and suppliers of the above-listed ingredients(and the corresponding trade names) can be found in InternationalCosmetic Ingredient Dictionary Handbook, 12^(th) Edition (2008), whichis incorporated by reference. Further, the extracts identified above canbe produced by obtaining the corresponding fruit, seed, leaf, etc. toproduce the extract by extraction methods which are known to those ofordinary skill in the art. The inventors also contemplate that otherportions of the substrate (e.g., Arctium lappa (Burdock) root extract,Epilobium angustifolium (Canadian Willowherb) extract, Pinus sylvestrisbark extract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, Hydrolyzed soy protein, Navybean extract, or Mushroom extract) producing the extract can be used inthe compositions and methods of the present invention. Non-limitingexamples of the other portions include the whole fruit, whole vegetable,whole plant, whole tree, whole bush, seed, peel, fruit, stem, bark,leaf, root, flower, petal, bulb, etc. These other portions are describedin the International Cosmetic Ingredient Dictionary Handbook, 12^(th)Edition (2008), which is incorporated by reference.

B. Additional Anti-Acne Ingredients

Additional anti-acne ingredients can also be incorporated in thecompositions of the present invention. Non-limiting examples of suchadditional ingredients include salicylic acid, benzoic acid, benzoylperoxide, and tretinoin. These forms of anti-acne ingredient when usedin effective amounts tend to produce dry, flaky, scaly skin and can alsoirritate the skin. These adverse symptoms can be reduced or preventedwhen the ingredients are incorporated into the compositions of thepresent invention. The symptoms can be reduced or prevented in instanceswhere an effective amount (or excess of an effective amount) of suchingredients are used. This is an added benefit of the compositions ofthe present invention in that the efficacy of the compositions can beincreased by use of such skin-caustic ingredients (e.g., salicylic acid,benzoic acid, benzoyl peroxide, and tretinoin) while preventing orreducing the unwanted side-effects produced by the caustic ingredients.

C. Oxygen Radical Absorbance Capacity

Oxygen Radical Absorption (or Absorbance) Capacity (ORAC) is an assaythat measures the antioxidant activity of an ingredient or composition.In essence, it can quantify the degree and length of time it takes toinhibit the action of an oxidizing agent such as oxygen radicals thatare known to cause damage cells (e.g., skin cells). The ORAC value ofthe compositions of the present invention can be determined by methodsknown to those of ordinary skill in the art (see U.S. Publication Nos.2004/0109905 and 2005/0163880; Cao et al. (1993)), all of which areincorporated by reference). In summary, the assay described in Cao etal. (1993) measures the ability of antioxidant compounds in testmaterials to inhibit the decline of B-phycoerythrm (B-PE) fluorescencethat is induced by a peroxyl radical generator, AAPH.

D. Compositions of the Present Invention

It is contemplated that the compositions of the present invention caninclude Arctium lappa (Burdock) root extract, Epilobium angustifolium(Canadian Willowherb) extract, Pinus sylvestris bark extract, Ribesnigrum (Black Currant) leaf extract, Peumus boldus (Boldo) leaf extract,Spiraea ulmaria (Meadow Sweet) extract, Cystoseira amentacea/CaespitosaBrachycarpa extract, Hydrolyzed soy protein, Navy bean extract, Mushroomextract, an anti-acne ingredient (e.g., salicylic acid, benzoic acid,benzoyl peroxide, tretinoin, etc.), or an additional ingredient, or anycombination thereof. Additionally, the compositions can include anynumber of combinations of additional ingredients described throughoutthis specification. The concentrations of the any ingredient within thecompositions can vary. In non-limiting embodiments, for example, thecompositions can comprise, consisting essentially of, or consist of, intheir final form, for example, at least about 0.0001%, 0.0002%, 0.0003%,0.0004%, 0.0005%, 0.0006%, 0.0007%, 0.0008%, 0.0009%, 0.0010%, 0.0011%,0.0012%, 0.0013%, 0.0014%, 0.0015%, 0.0016%, 0.0017%, 0.0018%, 0.0019%,0.0020%, 0.0021%, 0.0022%, 0.0023%, 0.0024%, 0.0025%, 0.0026%, 0.0027%,0.0028%, 0.0029%, 0.0030%, 0.0031%, 0.0032%, 0.0033%, 0.0034%, 0.0035%,0.0036%, 0.0037%, 0.0038%, 0.0039%, 0.0040%, 0.0041%, 0.0042%, 0.0043%,0.0044%, 0.0045%, 0.0046%, 0.0047%, 0.0048%, 0.0049%, 0.0050%, 0.0051%,0.0052%, 0.0053%, 0.0054%, 0.0055%, 0.0056%, 0.0057%, 0.0058%, 0.0059%,0.0060%, 0.0061%, 0.0062%, 0.0063%, 0.0064%, 0.0065%, 0.0066%, 0.0067%,0.0068%, 0.0069%, 0.0070%, 0.0071%, 0.0072%, 0.0073%, 0.0074%, 0.0075%,0.0076%, 0.0077%, 0.0078%, 0.0079%, 0.0080%, 0.0081%, 0.0082%, 0.0083%,0.0084%, 0.0085%, 0.0086%, 0.0087%, 0.0088%, 0.0089%, 0.0090%, 0.0091%,0.0092%, 0.0093%, 0.0094%, 0.0095%, 0.0096%, 0.0097%, 0.0098%, 0.0099%,0.0100%, 0.0200%, 0.0250%, 0.0275%, 0.0300%, 0.0325%, 0.0350%, 0.0375%,0.0400%, 0.0425%, 0.0450%, 0.0475%, 0.0500%, 0.0525%, 0.0550%, 0.0575%,0.0600%, 0.0625%, 0.0650%, 0.0675%, 0.0700%, 0.0725%, 0.0750%, 0.0775%,0.0800%, 0.0825%, 0.0850%, 0.0875%, 0.0900%, 0.0925%, 0.0950%, 0.0975%,0.1000%, 0.1250%, 0.1500%, 0.1750%, 0.2000%, 0.2250%, 0.2500%, 0.2750%,0.3000%, 0.3250%, 0.3500%, 0.3750%, 0.4000%, 0.4250%, 0.4500%, 0.4750%,0.5000%, 0.5250%, 0.0550%, 0.5750%, 0.6000%, 0.6250%, 0.6500%, 0.6750%,0.7000%, 0.7250%, 0.7500%, 0.7750%, 0.8000%, 0.8250%, 0.8500%, 0.8750%,0.9000%, 0.9250%, 0.9500%, 0.9750%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%,1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%,2.8%, 2.9%, 3.0%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%,4.0%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5.0%, 5.1%,5.2%, 5.3%, 5.4%, 5.5%, 5.6%, 5.7%, 5.8%, 5.9%, 6.0%, 6.1%, 6.2%, 6.3%,6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9%, 7.0%, 7.1%, 7.2%, 7.3%, 7.4%, 7.5%,7.6%, 7.7%, 7.8%, 7.9%, 8.0%, 8.1%, 8.2%, 8.3%, 8.4%, 8.5%, 8.6%, 8.7%,8.8%, 8.9%, 9.0%, 9.1%, 9.2%, 9.3%, 9.4%, 9.5%, 9.6%, 9.7%, 9.8%, 9.9%,10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%,24%, 25%, 26%, 27%, 28%, 29%, 30%, 35%, 40%, 45%, 50%, 60%, 65%, 70%,75%, 80%, 85%, 90%, 95%, or 99% or any range derivable therein, of atleast one of the ingredients that are mentioned throughout thespecification and claims. In non-limiting aspects, the percentage can becalculated by weight or volume of the total composition. A person ofordinary skill in the art would understand that the concentrations canvary depending on the addition, substitution, and/or subtraction ofingredients in a given composition.

The disclosed compositions of the present invention may also includevarious antioxidants to retard oxidation of one or more components.Additionally, the prevention of the action of microorganisms can bebrought about by preservatives such as various antibacterial andantifungal agents, including but not limited to parabens (e.g.,methylparabens, propylparabens), chlorobutanol, phenol, sorbic acid,thimerosal or combinations thereof.

E. Vehicles

The compositions of the present invention can be incorporated into alltypes of vehicles. Non-limiting examples of suitable vehicles includeemulsions (e.g., water-in-oil, water-in-oil-in-water, oil-in-water,silicone-in-water, water-in-silicone, oil-in-water-in-oil,oil-in-water-in-silicone emulsions), creams, lotions, solutions (bothaqueous and hydro-alcoholic), anhydrous bases (such as lipsticks andpowders), gels, and ointments or by other method or any combination ofthe forgoing as would be known to one of ordinary skill in the art(Remington's, 1990). Variations and other appropriate vehicles will beapparent to the skilled artisan and are appropriate for use in thepresent invention. In certain aspects, it is important that theconcentrations and combinations of the compounds, ingredients, andagents be selected in such a way that the combinations are chemicallycompatible and do not form complexes which precipitate from the finishedproduct.

It is also contemplated that ingredients identified throughout thisspecification, including but not limited to Arctium lappa (Burdock) rootextract, Epilobium angustifolium (Canadian Willowherb) extract, Pinussylvestris bark extract, Ribes nigrum (Black Currant) leaf extract,Peumus boldus (Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet)extract, Cystoseira amentacea/Caespitosa Brachycarpa extract, Hydrolyzedsoy protein, Navy bean extract, Mushroom extract, or any combinationthereof, or an additional anti-acne ingredient (e.g., salicylic acid,benzoic acid, benzoyl peroxide, tretinoin, etc.), or any combinationthereof, can be individually or combinatorially encapsulated fordelivery to a target area such as skin. Non-limiting examples ofencapsulation techniques include the use of liposomes, vesicles, and/ornanoparticles (e.g., biodegradable and non-biodegradable colloidalparticles comprising polymeric materials in which the ingredient istrapped, encapsulated, and/or absorbed—examples include nanospheres andnanocapsules) that can be used as delivery vehicles to deliver theingredient to skin (see, e.g., U.S. Pat. Nos. 6,387,398; 6,203,802;5,411,744; Kreuter 1998).

F. Cosmetic Products and Articles of Manufacture

The composition of the present invention can also be used in manycosmetic products including, but not limited to, sunscreen products,sunless skin tanning products, hair products, finger nail products,moisturizing creams, skin benefit creams and lotions, softeners, daylotions, gels, ointments, foundations, night creams, lipsticks,cleansers, toners, masks, or other known cosmetic products orapplications. Additionally, the cosmetic products can be formulated asleave-on or rinse-off products. In certain aspects, the compositions ofthe present invention are stand-alone products.

G. Additional Ingredients

In addition to the Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, Pinus sylvestris barkextract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, Hydrolyzed soy protein, Navybean extract, Mushroom extract, and/or an additional anti-acneingredient (e.g., salicylic acid, benzoic acid, benzoyl peroxide,tretinoin, etc.) disclosed throughout this specification, compositionsof the present invention can include additional ingredients such ascosmetic ingredients and pharmaceutical active ingredients. Non-limitingexamples of these additional ingredients are described in the followingsubsections.

a. Cosmetic Ingredients

The CTFA International Cosmetic Ingredient Dictionary and Handbook (2004and 2008) describes a wide variety of non-limiting cosmetic ingredientsthat can be used in the context of the present invention. Examples ofthese ingredient classes include: fragrances (artificial and natural),dyes and color ingredients (e.g., Blue 1, Blue 1 Lake, Red 40, titaniumdioxide, D&C blue no. 4, D&C green no. 5, D&C orange no. 4, D&C red no.17, D&C red no. 33, D&C violet no. 2, D&C yellow no. 10, and D&C yellowno. 11), adsorbents, lubricants, solvents, moisturizers (including,e.g., emollients, humectants, film formers, occlusive agents, and agentsthat affect the natural moisturization mechanisms of the skin),water-repellants, UV absorbers (physical and chemical absorbers such asparaaminobenzoic acid (“PABA”) and corresponding PABA derivatives,titanium dioxide, zinc oxide, etc.), essential oils, vitamins (e.g. A,B, C, D, E, and K), trace metals (e.g. zinc, calcium and selenium),anti-irritants (e.g. steroids and non-steroidal anti-inflammatories),botanical extracts (e.g. aloe vera, chamomile, cucumber extract, ginkgobiloba, ginseng, and rosemary), anti-microbial agents, antioxidants(e.g., BHT and tocopherol), chelating agents (e.g., disodium EDTA andtetrasodium EDTA), preservatives (e.g., methylparaben andpropylparaben), pH adjusters (e.g., sodium hydroxide and citric acid),absorbents (e.g., aluminum starch octenylsuccinate, kaolin, corn starch,oat starch, cyclodextrin, talc, and zeolite), skin bleaching andlightening agents (e.g., hydroquinone and niacinamide lactate),humectants (e.g., sorbitol, urea, and manitol), exfoliants,waterproofing agents (e.g., magnesium/aluminum hydroxide stearate), skinconditioning agents (e.g., aloe extracts, allantoin, bisabolol,ceramides, dimethicone, hyaluronic acid, and dipotassium glycyrrhizate).Non-limiting examples of some of these ingredients are provided in thefollowing subsections.

b. UV Absorption Agents

UV absorption agents that can be used in combination with thecompositions of the present invention include chemical and physicalsunblocks. Non-limiting examples of chemical sunblocks that can be usedinclude para-aminobenzoic acid (PABA), PABA esters (glyceryl PABA,amyldimethyl PABA and octyldimethyl PABA), butyl PABA, ethyl PABA, ethyldihydroxypropyl PABA, benzophenones (oxybenzone, sulisobenzone,benzophenone, and benzophenone-1 through 12), cinnamates (octylmethoxycinnamate, isoamyl p-methoxycinnamate, octylmethoxy cinnamate,cinoxate, diisopropyl methyl cinnamate, DEA-methoxycinnamate, ethyldiisopropylcinnamate, glyceryl octanoate dimethoxycinnamate and ethylmethoxycinnamate), cinnamate esters, salicylates (homomethyl salicylate,benzyl salicylate, glycol salicylate, isopropylbenzyl salicylate, etc.),anthranilates, ethyl urocanate, homosalate, octisalate, dibenzoylmethanederivatives (e.g., avobenzone), octocrylene, octyl triazone, digalloytrioleate, glyceryl aminobenzoate, lawsone with dihydroxyacetone,ethylhexyl triazone, dioctyl butamido triazone, benzylidene malonatepolysiloxane, terephthalylidene dicamphor sulfonic acid, disodium phenyldibenzimidazole tetrasulfonate, diethylamino hydroxybenzoyl hexylbenzoate, bis diethylamino hydroxybenzoyl benzoate, bisbenzoxazoylphenyl ethylhexylimino triazine, drometrizole trisiloxane,methylene bis-benzotriazolyl tetramethylbutyiphenol, andbis-ethylhexyloxyphenol methoxyphenyltriazine,4-methylbenzylidenecamphor, and isopentyl 4-methoxycinnamate.Non-limiting examples of physical sunblocks include, kaolin, talc,petrolatum and metal oxides (e.g., titanium dioxide and zinc oxide).

c. Moisturizing Agents

Non-limiting examples of moisturizing agents that can be used with thecompositions of the present invention include amino acids, chondroitinsulfate, diglycerin, erythritol, fructose, glucose, glycerin, glycerolpolymers, glycol, 1,2,6-hexanetriol, honey, hyaluronic acid,hydrogenated honey, hydrogenated starch hydrolysate, inositol, lactitol,maltitol, maltose, mannitol, natural moisturizing factor, PEG-15butanediol, polyglyceryl sorbitol, salts of pyrollidone carboxylic acid,potassium PCA, propylene glycol, sodium glucuronate, sodium PCA,sorbitol, sucrose, trehalose, urea, and xylitol.

Other examples include acetylated lanolin, acetylated lanolin alcohol,alanine, algae extract, aloe barbadensis, aloe-barbadensis extract, aloebarbadensis gel, althea officinalis extract, apricot (prunus armeniaca)kernel oil, arginine, arginine aspartate, arnica montana extract,aspartic acid, avocado (persea gratissima) oil, barrier sphingolipids,butyl alcohol, beeswax, behenyl alcohol, beta-sitosterol, birch (betulaalba) bark extract, borage (borago officinalis) extract, butcherbroom(ruscus aculeatus) extract, butylene glycol, calendula officinalisextract, calendula officinalis oil, candelilla (euphorbia cerifera) wax,canola oil, caprylic/capric triglyceride, cardamon (elettariacardamomum) oil, carnauba (copernicia cerifera) wax, carrot (daucuscarota sativa) oil, castor (ricinus communis) oil, ceramides, ceresin,ceteareth-5, ceteareth-12, ceteareth-20, cetearyl octanoate, ceteth-20,ceteth-24, cetyl acetate, cetyl octanoate, cetyl palmitate, chamomile(anthemis nobilis) oil, cholesterol, cholesterol esters, cholesterylhydroxystearate, citric acid, clary (salvia sclarea) oil, cocoa(theobroma cacao) butter, coco-caprylate/caprate, coconut (cocosnucifera) oil, collagen, collagen amino acids, corn (zea mays) oil,fatty acids, decyl oleate, dimethicone copolyol, dimethiconol, dioctyladipate, dioctyl succinate, dipentaerythrityl hexacaprylate/hexacaprate,DNA, erythritol, ethoxydiglycol, ethyl linoleate, eucalyptus globulusoil, evening primrose (oenothera biennis) oil, fatty acids, geraniummaculatum oil, glucosamine, glucose glutamate, glutamic acid,glycereth-26, glycerin, glycerol, glyceryl distearate, glycerylhydroxystearate, glyceryl laurate, glyceryl linoleate, glycerylmyristate, glyceryl oleate, glyceryl stearate, glyceryl stearate SE,glycine, glycol stearate, glycol stearate SE, glycosaminoglycans, grape(vitis vinifera) seed oil, hazel (corylus americana) nut oil, hazel(corylus avellana) nut oil, hexylene glycol, hyaluronic acid, hybridsafflower (carthamus tinctorius) oil, hydrogenated castor oil,hydrogenated coco-glycerides, hydrogenated coconut oil, hydrogenatedlanolin, hydrogenated lecithin, hydrogenated palm glyceride,hydrogenated palm kernel oil, hydrogenated soybean oil, hydrogenatedtallow glyceride, hydrogenated vegetable oil, hydrolyzed collagen,hydrolyzed elastin, hydrolyzed glycosaminoglycans, hydrolyzed keratin,hydrolyzed soy protein, hydroxylated lanolin, hydroxyproline, isocetylstearate, isocetyl stearoyl stearate, isodecyl oleate, isopropylisostearate, isopropyl lanolate, isopropyl myristate, isopropylpalmitate, isopropyl stearate, isostearamide DEA, isostearic acid,isostearyl lactate, isostearyl neopentanoate, jasmine (jasminumofficinale) oil, jojoba (buxus chinensis) oil, kelp, kukui (aleuritesmoluccana) nut oil, lactamide MEA, laneth-16, laneth-10 acetate,lanolin, lanolin acid, lanolin alcohol, lanolin oil, lanolin wax,lavender (lavandula angustifolia) oil, lecithin, lemon (citrus medicalimonum) oil, linoleic acid, linolenic acid, macadamia ternifolia nutoil, maltitol, matricaria (chamomilla recutita) oil, methyl glucosesesquistearate, methylsilanol PCA, mineral oil, mink oil, mortierellaoil, myristyl lactate, myristyl myristate, myristyl propionate,neopentyl glycol dicaprylate/dicaprate, octyldodecanol, octyldodecylmyristate, octyldodecyl stearoyl stearate, octyl hydroxystearate, octylpalmitate, octyl salicylate, octyl stearate, oleic acid, olive (oleaeuropaea) oil, orange (citrus aurantium dulcis) oil, palm (elaeisguineensis) oil, palmitic acid, pantethine, panthenol, panthenyl ethylether, paraffin, PCA, peach (prunus persica) kernel oil, peanut (arachishypogaea) oil, PEG-8 C12-18 ester, PEG-15 cocamine, PEG-150 distearate,PEG-60 glyceryl isostearate, PEG-5 glyceryl stearate, PEG-30 glycerylstearate, PEG-7 hydrogenated castor oil, PEG-40 hydrogenated castor oil,PEG-60 hydrogenated castor oil, PEG-20 methyl glucose sesquistearate,PEG40 sorbitan peroleate, PEG-5 soy sterol, PEG-10 soy sterol, PEG-2stearate, PEG-8 stearate, PEG-20 stearate, PEG-32 stearate, PEG40stearate, PEG-50 stearate, PEG-100 stearate, PEG-150 stearate,pentadecalactone, peppermint (mentha piperita) oil, petrolatum,phospholipids, polyamino sugar condensate, polyglyceryl-3 diisostearate,polyquaternium-24, polysorbate 20, polysorbate 40, polysorbate 60,polysorbate 80, polysorbate 85, potassium myristate, potassiumpalmitate, propylene glycol, propylene glycol dicaprylate/dicaprate,propylene glycol dioctanoate, propylene glycol dipelargonate, propyleneglycol laurate, propylene glycol stearate, propylene glycol stearate SE,PVP, pyridoxine dipalmitate, retinol, retinyl palmitate, rice (oryzasativa) bran oil, RNA, rosemary (rosmarinus officinalis) oil, rose oil,safflower (carthamus tinctorius) oil, sage (salvia officinalis) oil,sandalwood (santalum album) oil, serine, serum protein, sesame (sesamumindicum) oil, shea butter (butyrospermum parkii), silk powder, sodiumchondroitin sulfate, sodium hyaluronate, sodium lactate, sodiumpalmitate, sodium PCA, sodium polyglutamate, soluble collagen, sorbitanlaurate, sorbitan oleate, sorbitan palmitate, sorbitan sesquioleate,sorbitan stearate, sorbitol, soybean (glycine soja) oil, sphingolipids,squalane, squalene, stearamide MEA-stearate, stearic acid, stearoxydimethicone, stearoxytrimethylsilane, stearyl alcohol, stearylglycyrrhetinate, stearyl heptanoate, stearyl stearate, sunflower(helianthus annuus) seed oil, sweet almond (prunus amygdalus dulcis)oil, synthetic beeswax, tocopherol, tocopheryl acetate, tocopheryllinoleate, tribehenin, tridecyl neopentanoate, tridecyl stearate,triethanolamine, tristearin, urea, vegetable oil, water, waxes, wheat(triticum vulgare) germ oil, and ylang ylang (cananga odorata) oil.

d. Antioxidants

Non-limiting examples of antioxidants that can be used with thecompositions of the present invention include acetyl cysteine, ascorbicacid polypeptide, ascorbyl dipalmitate, ascorbyl methylsilanolpectinate, ascorbyl palmitate, ascorbyl stearate, BHA, BHT, t-butylhydroquinone, cysteine, cysteine HCl, diamylhydroquinone,di-t-butylhydroquinone, dicetyl thiodipropionate, dioleyl tocopherylmethylsilanol, disodium ascorbyl sulfate, distearyl thiodipropionate,ditridecyl thiodipropionate, dodecyl gallate, erythorbic acid, esters ofascorbic acid, ethyl ferulate, ferulic acid, gallic acid esters,hydroquinone, isooctyl thioglycolate, kojic acid, magnesium ascorbate,magnesium ascorbyl phosphate, methylsilanol ascorbate, natural botanicalanti-oxidants such as green tea or grape seed extracts,nordihydroguaiaretic acid, octyl gallate, phenylthioglycolic acid,potassium ascorbyl tocopheryl phosphate, potassium sulfite, propylgallate, quinones, rosmarinic acid, sodium ascorbate, sodium bisulfite,sodium erythorbate, sodium metabisulfite, sodium sulfite, superoxidedismutase, sodium thioglycolate, sorbityl furfural, thiodiglycol,thiodiglycolamide, thiodiglycolic acid, thioglycolic acid, thiolacticacid, thiosalicylic acid, tocophereth-5, tocophereth-10, tocophereth-12,tocophereth-18, tocophereth-50, tocopherol, tocophersolan, tocopherylacetate, tocopheryl linoleate, tocopheryl nicotinate, tocopherylsuccinate, and tris(nonylphenyl)phosphite.

e. Structuring Agents

In other non-limiting aspects, the compositions of the present inventioncan include a structuring agent. Structuring agent, in certain aspects,assist in providing rheological characteristics to the composition tocontribute to the composition's stability. In other aspects, structuringagents can also function as an emulsifier or surfactant. Non-limitingexamples of structuring agents include stearic acid, palmitic acid,stearyl alcohol, cetyl alcohol, behenyl alcohol, stearic acid, palmiticacid, the polyethylene glycol ether of stearyl alcohol having an averageof about 1 to about 21 ethylene oxide units, the polyethylene glycolether of cetyl alcohol having an average of about 1 to about 5 ethyleneoxide units, and mixtures thereof.

f. Emulsifiers

In certain aspects of the present invention, the compositions do notinclude an emulsifier. In other aspects, however, the compositions caninclude one or more emulsifiers. Emulsifiers can reduce the interfacialtension between phases and improve the formulation and stability of anemulsion. The emulsifiers can be nonionic, cationic, anionic, andzwitterionic emulsifiers (See McCutcheon's (1986); U.S. Pat. Nos.5,011,681; 4,421,769; 3,755,560). Non-limiting examples include estersof glycerin, esters of propylene glycol, fatty acid esters ofpolyethylene glycol, fatty acid esters of polypropylene glycol, estersof sorbitol, esters of sorbitan anhydrides, carboxylic acid copolymers,esters and ethers of glucose, ethoxylated ethers, ethoxylated alcohols,alkyl phosphates, polyoxyethylene fatty ether phosphates, fatty acidamides, acyl lactylates, soaps, TEA stearate, DEA oleth-3 phosphate,polyethylene glycol 20 sorbitan monolaurate (polysorbate 20),polyethylene glycol 5 soya sterol, steareth-2, steareth-20, steareth-21,ceteareth-20, PPG-2 methyl glucose ether distearate, ceteth-10,polysorbate 80, cetyl phosphate, potassium cetyl phosphate,diethanolamine cetyl phosphate, polysorbate 60, glyceryl stearate,PEG-100 stearate, and mixtures thereof.

g. Silicone Containing Compounds

In non-limiting aspects, silicone containing compounds include anymember of a family of polymeric products whose molecular backbone ismade up of alternating silicon and oxygen atoms with side groupsattached to the silicon atoms. By varying the —Si—O— chain lengths, sidegroups, and crosslinking, silicones can be synthesized into a widevariety of materials. They can vary in consistency from liquid to gel tosolids.

The silicone containing compounds that can be used in the context of thepresent invention include those described in this specification or thoseknown to a person of ordinary skill in the art. Non-limiting examplesinclude silicone oils (e.g., volatile and non-volatile oils), gels, andsolids. In certain aspects, the silicon containing compounds includes asilicone oils such as a polyorganosiloxane. Non-limiting examples ofpolyorganosiloxanes include dimethicone, cyclomethicone,polysilicone-11, phenyl trimethicone, trimethylsilylamodimethicone,stearoxytrimethylsilane, or mixtures of these and other organosiloxanematerials in any given ratio in order to achieve the desired consistencyand application characteristics depending upon the intended application(e.g., to a particular area such as the skin, hair, or eyes). A“volatile silicone oil” includes a silicone oil have a low heat ofvaporization, i.e. normally less than about 50 cal per gram of siliconeoil. Non-limiting examples of volatile silicone oils include:cyclomethicones such as Dow Corning 344 Fluid, Dow Corning 345 Fluid,Dow Corning 244 Fluid, and Dow Corning 245 Fluid, Volatile Silicon 7207(Union Carbide Corp., Danbury, Conn.); low viscosity dimethicones, i.e.dimethicones having a viscosity of about 50 cst or less (e.g.,dimethicones such as Dow Corning 200-0.5 cst Fluid). The Dow CorningFluids are available from Dow Corning Corporation, Midland, Mich.Cyclomethicone and dimethicone are described in the Third Edition of theCTFA Cosmetic Ingredient Dictionary (incorporated by reference) ascyclic dimethyl polysiloxane compounds and a mixture of fully methylatedlinear siloxane polymers end-blocked with trimethylsiloxy units,respectively. Other non-limiting volatile silicone oils that can be usedin the context of the present invention include those available fromGeneral Electric Co., Silicone Products Div., Waterford, N.Y. and SWSSilicones Div. of Stauffer Chemical Co., Adrian, Mich.

h. Essential Oils

Essential oils include oils derived from herbs, flowers, trees, andother plants. Such oils are typically present as tiny droplets betweenthe plant's cells, and can be extracted by several method known to thoseof skill in the art (e.g., steam distilled, enfleurage (i.e., extractionby using fat), maceration, solvent extraction, or mechanical pressing).When these types of oils are exposed to air they tend to evaporate(i.e., a volatile oil). As a result, many essential oils are colorless,but with age they can oxidize and become darker. Essential oils areinsoluble in water and are soluble in alcohol, ether, fixed oils(vegetal), and other organic solvents. Typical physical characteristicsfound in essential oils include boiling points that vary from about 160°to 240° C. and densities ranging from about 0.759 to about 1.096.

Essential oils typically are named by the plant from which the oil isfound. For example, rose oil or peppermint oil are derived from rose orpeppermint plants, respectively. Non-limiting examples of essential oilsthat can be used in the context of the present invention include sesameoil, macadamia nut oil, tea tree oil, evening primrose oil, Spanish sageoil, Spanish rosemary oil, coriander oil, thyme oil, pimento berriesoil, rose oil, anise oil, balsam oil, bergamot oil, rosewood oil, cedaroil, chamomile oil, sage oil, clary sage oil, clove oil, cypress oil,eucalyptus oil, fennel oil, sea fennel oil, frankincense oil, geraniumoil, ginger oil, grapefruit oil, jasmine oil, juniper oil, lavender oil,lemon oil, lemongrass oil, lime oil, mandarin oil, marjoram oil, myrrhoil, neroli oil, orange oil, patchouli oil, pepper oil, black pepperoil, petitgrain oil, pine oil, rose otto oil, rosemary oil, sandalwoodoil, spearmint oil, spikenard oil, vetiver oil, wintergreen oil, orylang ylang. Other essential oils known to those of skill in the art arealso contemplated as being useful within the context of the presentinvention.

i. Thickening Agents

Thickening agents, including thickener or gelling agents, includesubstances which that can increase the viscosity of a composition.Thickeners includes those that can increase the viscosity of acomposition without substantially modifying the efficacy of the activeingredient within the composition. Thickeners can also increase thestability of the compositions of the present invention. In certainaspects of the present invention, thickeners include hydrogenatedpolyisobutene or trihydroxystearin, or a mixture of both.

Non-limiting examples of additional thickening agents that can be usedin the context of the present invention include carboxylic acidpolymers, crosslinked polyacrylate polymers, polyacrylamide polymers,polysaccharides, and gums. Examples of carboxylic acid polymers includecrosslinked compounds containing one or more monomers derived fromacrylic acid, substituted acrylic acids, and salts and esters of theseacrylic acids and the substituted acrylic acids, wherein thecrosslinking agent contains two or more carbon-carbon double bonds andis derived from a polyhydric alcohol (see U.S. Pat. Nos. 5,087,445;4,509,949; 2,798,053; CTFA International Cosmetic Ingredient Dictionary,Fourth edition, 1991, pp. 12 and 80). Examples of commercially availablecarboxylic acid polymers include carbomers, which are homopolymers ofacrylic acid crosslinked with allyl ethers of sucrose or pentaerytritol(e.g., Carbopol™ 900 series from B. F. Goodrich).

Non-limiting examples of crosslinked polyacrylate polymers includecationic and nonionic polymers. Examples are described in U.S. Pat. Nos.5,100,660; 4,849,484; 4,835,206; 4,628,078; 4,599,379).

Non-limiting examples of polyacrylamide polymers (including nonionicpolyacrylamide polymers including substituted branched or unbranchedpolymers) include polyacrylamide, isoparaffin and laureth-7, multi-blockcopolymers of acrylamides and substituted acrylamides with acrylic acidsand substituted acrylic acids.

Non-limiting examples of polysaccharides include cellulose,carboxymethyl hydroxyethylcellulose, cellulose acetate propionatecarboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose,hydroxypropylcellulose, hydroxypropyl methylcellulose, methylhydroxyethylcellulose, microcrystalline cellulose, sodium cellulosesulfate, and mixtures thereof. Another example is an alkyl substitutedcellulose where the hydroxy groups of the cellulose polymer ishydroxyalkylated (preferably hydroxy ethylated or hydroxypropylated) toform a hydroxyalkylated cellulose which is then further modified with aC₁₀-C₃₀ straight chain or branched chain alkyl group through an etherlinkage. Typically these polymers are ethers of C₁₀-C₃₀ straight orbranched chain alcohols with hydroxyalkylcelluloses. Other usefulpolysaccharides include scleroglucans comprising a linear chain of (1-3)linked glucose units with a (1-6) linked glucose every three unit.

Non-limiting examples of gums that can be used with the presentinvention include acacia, agar, algin, alginic acid, ammonium alginate,amylopectin, calcium alginate, calcium carrageenan, carnitine,carrageenan, dextrin, gelatin, gellan gum, guar gum, guarhydroxypropyltrimonium chloride, hectorite, hyaluroinic acid, hydratedsilica, hydroxypropyl chitosan, hydroxypropyl guar, karaya gum, kelp,locust bean gum, natto gum, potassium alginate, potassium carrageenan,propylene glycol alginate, sclerotium gum, sodium carboyxmethyl dextran,sodium carrageenan, tragacanth gum, xanthan gum, and mixtures thereof.

j. Preservatives

Non-limiting examples of preservatives that can be used in the contextof the present invention include quaternary ammonium preservatives suchas polyquaternium-1 and benzalkonium halides (e.g., benzalkoniumchloride (“BAC”) and benzalkonium bromide), parabens (e.g.,methylparabens and propylparabens), phenoxyethanol, benzyl alcohol,chlorobutanol, phenol, sorbic acid, thimerosal or combinations thereof.

H. Pharmaceutical Ingredients

Pharmaceutical active agents are also contemplated as being useful withthe compositions of the present invention. Non-limiting examples ofpharmaceutical active agents include agents used to treat rosacea,analgesics, anesthetics, anorectals, antihistamines, anti-inflammatoryagents including non-steroidal anti-inflammatory drugs, antibiotics,antifungals, antivirals, antimicrobials, anti-cancer actives,scabicides, pediculicides, antineoplastics, antiperspirants,antipruritics, antipsoriatic agents, anti seborrheic agents,biologically active proteins and peptides, burn treatment agents,cauterizing agents, depigmenting agents, depilatories, diaper rashtreatment agents, enzymes, hair growth stimulants, hair growthretardants including DFMO and its salts and analogs, hemostatics,kerotolytics, canker sore treatment agents, cold sore treatment agents,dental and periodontal treatment agents, photosensitizing actives, skinprotectant/barrier agents, steroids including hormones andcorticosteroids, sunburn treatment agents, sunscreens, transdermalactives, nasal actives, vaginal actives, wart treatment agents, woundtreatment agents, wound healing agents, etc.

I. Kits

Kits are also contemplated as being used in certain aspects of thepresent invention. For instance, compositions of the present inventioncan be included in a kit. A kit can include a container. Containers caninclude a bottle, a metal tube, a laminate tube, a plastic tube, adispenser, a pressurized container, a barrier container, a package, acompartment, a lipstick container, a compact container, cosmetic pansthat can hold cosmetic compositions, or other types of containers suchas injection or blow-molded plastic containers into which thedispersions or compositions or desired bottles, dispensers, or packagesare retained. The kit and/or container can include indicia on itssurface. The indicia, for example, can be a word, a phrase, anabbreviation, a picture, or a symbol.

The containers can dispense a pre-determined amount of the composition.In other embodiments, the container can be squeezed (e.g., metal,laminate, or plastic tube) to dispense a desired amount of thecomposition. The composition can be dispensed as a spray, an aerosol, aliquid, a fluid, or a semi-solid. The containers can have spray, pump,or squeeze mechanisms. A kit can also include instructions for employingthe kit components as well the use of any other compositions included inthe container. Instructions can include an explanation of how to apply,use, and maintain the compositions.

EXAMPLES

The following examples are included to demonstrate certain non-limitingaspects of the invention. It should be appreciated by those of skill inthe art that the techniques disclosed in the examples which followrepresent techniques discovered by the inventor to function well in thepractice of the invention. However, those of skill in the art should, inlight of the present disclosure, appreciate that many changes can bemade in the specific embodiments which are disclosed and still obtain alike or similar result without departing from the spirit and scope ofthe invention.

Example 1 Testing Vehicles

Non-limiting examples of compositions of the present invention aredescribed in Tables 1 and 2. These compositions can be used as vehiclesto test the efficacy of the active ingredients to treat skin.

TABLE 1* % Concentration Ingredient (by weight) Phase A Water q.s. to100% Xanthum gum 0.1 M-paraben 0.15 P-paraben 0.1 Citric acid 0.01 PhaseB Cetyl alcohol 4.0 Glyceryl stearate + PEG 100 4.0 Octyl palmitate 4.0Dimethicone 1.0 Tocopheryl acetate 0.2 Phase C Active Ingredients** 2.0*Sprinkle Xanthum gum in water and mix for 10 min. Subsequently, add allingredients in phase A and heat to 70-75° C. Add all items in phase B toseparate beaker and heat to 70-75° C. Mix phases A and B at 70-75° C.Continue mixing and allow composition to cool to 30° C. Subsequently,add phase C ingredient while mixing. **Any of the active ingredients (orcombination thereof) described in the specification can be used. Forinstance, the active ingredients can include Arctium lappa (Burdock)root extract, Epilobium angustifolium (Canadian Willowherb) extract,Pinus sylvestris bark extract, Ribes nigrum (Black Currant) leafextract, Peumus boldus (Boldo) leaf extract, Spiraea ulmaria (MeadowSweet) extract, Cystoseira amentacea/Caespitosa Brachycarpa extract,Hydrolyzed soy protein, Navy bean extract, Mushroom extract, or ananti-acne ingredient (e.g., salicylic acid, benzylic acid, benzoylperoxide, tretinoin, etc.) or any combination thereof. Although thetotal amount of active ingredients in the Table 1 formulation is 2% w/w,it is contemplated that the amount of active ingredients can beincreased or decreased to achieve a desired result, where the wateramount can be increased/decreased accordingly (e.g., q.s.).

TABLE 2* % Concentration Ingredient (by weight) Phase A Water q.s. to100% M-paraben 0.2 P-paraben 0.1 Na2 EDTA 0.1 Shea butter 4.5 Petrolatum4.5 Glycerin 4.0 Propylene Glycol 2.0 Finsolve TN 2.0 Phase B Sepigel305 2.0 Phase C Active Ingredient(s)** 2.0 *Add ingredients in phase Ato beaker and heat to 70-75° C. while mixing. Subsequently, add thephase B ingredient with phase A and cool to 30° C. with mixing.Subsequently, add phase C ingredient while mixing. **Any of the activeingredients (or combination thereof) described in the specification canbe used. For instance, the active ingredients can include Arctium lappa(Burdock) root extract, Epilobium angustifolium (Canadian Willowherb)extract, Pinus sylvestris bark extract, Ribes nigrum (Black Currant)leaf extract, Peumus boldus (Boldo) leaf extract, Spiraea ulmaria(Meadow Sweet) extract, Cystoseira amentacea/Caespitosa Brachycarpaextract, Hydrolyzed soy protein, Navy bean extract, Mushroom extract, oran anti-acne ingredient (e.g., salicylic acid, benzylic acid, benzoylperoxide, tretinoin, etc.) or any combination thereof. Although thetotal amount of active ingredients in the Table 1 formulation is 2% w/w,it is contemplated that the amount of active ingredients can beincreased or decreased to achieve a desired result, where the wateramount can be increased/decreased accordingly (e.g., q.s.).

Example 2 Non-Limiting Product Formulations

Non-limiting skin product formulations of the present invention isdescribed in Tables 3-9. The compositions can be made by any knownmethods in the art. For instance, simple mixing of the ingredients intoa container can be used. Further, it is contemplated that additionalingredients can be added to the product formulations, listed ingredientscan be replaced, and/or listed ingredients can be removed. Theconcentration ranges of the ingredients can be modified.

TABLE 3 (Cleanser) % Concentration Ingredient (by weight) Water q.s. to100% Sodium C14-16 Olefin Sulfonate 17.0 Cocamidopropyl Betaine 6.0Sodium Chloride 2.0 Salicylic Acid 0.5 Disodium EDTA 0.3 Phenoxyethanol0.1 Butylene Glycol 0.1 Propylene Glycol 0.1 Citric Acid 0.1 BotanicalExtracts* 0.01 *Mixture of Arctium lappa (Burdock) root extract,Epilobium angustifolium (Canadian Willowherb) extract, and Cystoseiraamentacea/Caespitosa Brachycarpa extract.

TABLE 4 (Lotion) % Concentration Ingredient (by weight) Water q.s. to100% Butylene Glycol 3.0 Dimethicone 3.0 Glycerin 2.0 AmmoniumAcryloyldimethyltaurate/VP 1.0 Polysorbate 20 1.0 Propylene Glycol 1.0Salicylic Acid 0.5 Triethanolamine 0.5 Butyl Avocadate 0.5Phenoxyethanol 0.1 Citric Acid 0.05 Botanical Extracts* 0.1 *Mixture ofArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, and Cystoseira amentacea/Caespitosa Brachycarpaextract.

TABLE 5 (Cream) % Concentration Ingredient (by weight) Water q.s. to100% Ethylhexyl Palmitate 10.0 Stearyl Alcohol 4.0 Glycerin 3.0Propylene Glycol 1.0 Polysorbate 60 1.0 Salicylic Acid 0.5Triethanolamine 0.5 Butyl Avocadate 0.5 Citric Acid 0.1 Butylene Glycol0.01 Botanical Extracts* 0.1 *Mixture of Arctium lappa (Burdock) rootextract, Epilobium angustifolium (Canadian Willowherb) extract, andCystoseira amentacea/Caespitosa Brachycarpa extract.

TABLE 6 (Body Spray) % Concentration Ingredient (by weight) Water q.s.to 100% Denatured Alcohol 35.0 Butylene Glycol 5.0 Salicylic Acid 2.0Panthenol 0.3 Butylene Glycol 0.01 Citric Acid 0.1 Botanical Extracts*0.1 *Mixture of Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, and Cystoseiraamentacea/Caespitosa Brachycarpa extract.

TABLE 7 (Cream) % Concentration Ingredient (by weight) Water q.s. to100% Ethylhexyl Palmitate 10.0 Stearyl Alcohol 4.0 Glycerin 3.0Triethanolamine 2.0 Salicylic Acid 2.0 Polysorbate 60 1.0 PropyleneGlycol 1.0 Glyceryl Stearate 0.5 Dimethicone/Vinyl DimethiconeCrosspolymer 0.5 Retinly Palmitate 0.5 Steareth-20 0.5 Butyl Avocadate0.5 Ethylene/Acrylic Acid Copolymer 0.5 Butylene Glycol 0.01 Citric Acid0.1 Botanical Extracts** 0.1 *Mixture of Arctium lappa (Burdock) rootextract, Epilobium angustifolium (Canadian Willowherb) extract, andCystoseira amentacea/Caespitosa Brachycarpa extract.

TABLE 8 (Serum) % Concentration Ingredient (by weight) Water q.s. to100% Butylene Glycol 4.0 Dimethicone 3.0 Salicylic Acid 2.0Triethanolamine 2.0 Glycerin 2.0 Ammonium Acryloyldimethyltaurate/VPCopol. 2.0 Propylene Glycol 1.0 Polysorbate 20 1.0 Butyl Avocadate 0.5Citric Acid 0.1 Botanical Extracts** 0.1 *Mixture of Arctium lappa(Burdock) root extract, Epilobium angustifolium (Canadian Willowherb)extract, and Cystoseira amentacea/Caespitosa Brachycarpa extract.

TABLE 9 (Cleanser) % Concentration Ingredient (by weight) Water q.s. to100% Sodium C14-16 Olefin Sulfonate 17.0 Cocamidopropyl Betain 6.0Salicylic Acid 2.0 Sodium Chloride 1.0 Triethanolamine 0.5 ButyleneGlycol 0.1 Propylene Glycol 0.1 Citric Acid 0.1 Botanical Extracts**0.01 *Mixture of Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, and Cystoseiraamentacea/Caespitosa Brachycarpa extract.

Example 3 Reduced Expression of Pro-Inflammatory Cytokines

Problem:

The increased bacterial lode within acne lesions draws inflammatorycells into the area stimulated by the increased expression ofpro-inflammatory cytokines. As acne lesions emerge, inflammation occursas the skin attempts to heal itself. Overall, redness of the skinsurrounding the acne lesion is intensified by the release ofpro-inflammatory cytokines.

Solution:

In vitro testing was used to examine the effect of plant extractsArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, and Cystoseira amentacea/Caespitosa Brachycarpaextract to reduce the expression of IL-8, IL-2, and TNF-αpro-inflammatory cytokines, which can contribute to a reduction in theintense erythema associated with acne lesions and acne prone skin.

Materials and Methods:

Human adult epidermal keratinocytes were cultured at 37° C. and 5.0% CO₂in standard growth medium. At 70-80% confluent, cells were treated withplant extracts for 5 h in the presence or absence of phorbol myristylacetate. Following, all media was collected and assayed for inflammatorycytokine production analysis using the FaST Quant Kit—MicroSpot ELISAFollowing blocking, supernatant was added to each array. Each arraycontains triplicate spots for each cytokine. Arrays were incubated for 3hours and treated with an antibody cocktail, containing one biotinylatedantibody corresponding to each of the arrayed capture antibodies. Arrayswere incubated for 1 h and incubated with a streptavidin-Cy5. Arrayswere imaged on a Perkin-Elmer ScanArray 4000 confocal fluorescentimaging system. Array images were analyzed using Imaging ResearchArrayVision software. Spot intensities were determined by subtractingbackground signal. Spot replicates were averaged and compared to theappropriate controls. Data was calculated as a percent change fromappropriate controls.

Results:

A summary of the results is in FIG. 1. These data demonstrate thatArctium lappa (Burdock) root extract, Epilobium angustifolium (CanadianWillowherb) extract, and Cystoseira amentacea/Caespitosa Brachycarpaextract can act to reduce the expression of known inflammatory cytokinesin human epidermal keratinocytes induced by chemical treatment.Together, these data support the ability of these botanical to reducethe potential for skin irritation associated with acne prone skin.

Example 4 Determining Efficacy of the Compositions of the PresentInvention

The efficacy of compositions or active ingredients within a givencomposition of the present inventions can be determined by methods knownto those of ordinary skill in the art. The following are non-limitingprocedures that can be used in the context of the present invention. Itshould be recognized that other testing procedures can be used,including, for example, objective and subjective procedures. The activeingredients (e.g., Arctium lappa (Burdock) root extract, Epilobiumangustifolium (Canadian Willowherb) extract, Pinus sylvestris barkextract, Ribes nigrum (Black Currant) leaf extract, Peumus boldus(Boldo) leaf extract, Spiraea ulmaria (Meadow Sweet) extract, Cystoseiraamentacea/Caespitosa Brachycarpa extract, or an anti-acne ingredient(e.g., salicylic acid, benzylic acid, benzoyl peroxide, tretinoin, etc.)or any combination thereof, can be tested for their skin efficacy byusing the composition vehicles identified in Tables 1 and 2. As noted inthese Tables, the active ingredients and concentration ranges can vary.

Acne treatment can be visually monitored by applying a treatmentcomposition to acne associated symptoms (e.g., open or closed comedones,papules (pimples), pustules, nodulocystic lesions, etc.) and inspectingthe symptom over a period of time (e.g., 1, 2, 3, 4, 5, 6, days, 1, 2,3, 4, weeks, 1, 2, 3, 4, months, etc.). Similarly, Acne prevention canbe visually monitored by applying a prevention composition to skinsusceptible of exhibiting an acne associated symptom (e.g., chin, cheek,eye, nose, forehead, etc., skin of a child, teenage, young adult, adult,or senior citizen) and inspecting the skin over a period of time.Further, the existence of symptoms associated with acne treatment (e.g.,dry, flaky, or scaly skin or irritated skin) can be visually inspected.

Skin moisture/hydration can be measured by using impedance measurementswith the Nova Dermal Phase Meter. The impedance meter measures changesin skin moisture content. The outer layer of the skin has distinctelectrical properties. When skin is dry it conducts electricity verypoorly. As it becomes more hydrated increasing conductivity results.Consequently, changes in skin impedance (related to conductivity) can beused to assess changes in skin hydration. The unit can be calibratedaccording to instrument instructions for each testing day. A notation oftemperature and relative humidity can also be made. Subjects can beevaluated as follows: prior to measurement they can equilibrate in aroom with defined humidity (e.g., 30-50%) and temperature (e.g., 68-72C). Three separate impedance readings can be taken on each side of theface, recorded, and averaged. The T5 setting can be used on theimpedance meter which averages the impedance values of every fiveseconds application to the face. Changes can be reported withstatistical variance and significance.

Skin clarity and the reduction in freckles and age spots can beevaluated using a Minolta Chromometer. Changes in skin color can beassessed to determine irritation potential due to product treatmentusing the a* values of the Minolta Chroma Meter. The a* value measureschanges in skin color in the red region. This is used to determinewhether a composition is inducing irritation. The measurements can bemade on each side of the face and averaged, as left and right facialvalues. Skin clarity can also be measured using the Minolta Meter. Themeasurement is a combination of the a*, b, and L values of the MinoltaMeter and is related to skin brightness, and correlates well with skinsmoothness and hydration. Skin reading is taken as above. In onenon-limiting aspect, skin clarity can be described as L/C where C ischroma and is defined as (a²+b²)^(1/2).

Skin dryness, surface fine lines, skin smoothness, and skin tone can beevaluated with clinical grading techniques. For example, clinicalgrading of skin dryness can be determined by a five point standardKligman Scale: (0) skin is soft and moist; (1) skin appears normal withno visible dryness; (2) skin feels slightly dry to the touch with novisible flaking; (3) skin feels dry, tough, and has a whitish appearancewith some scaling; and (4) skin feels very dry, rough, and has a whitishappearance with scaling. Evaluations can be made independently by twoclinicians and averaged.

Clinical grading of skin tone can be performed via a ten point analognumerical scale: (10) even skin of uniform, pinkish brown color. Nodark, erythremic, or scaly patches upon examination with a hand heldmagnifying lens. Microtexture of the skin very uniform upon touch; (7)even skin tone observed without magnification. No scaly areas, butslight discolorations either due to pigmentation or erythema. Nodiscolorations more than 1 cm in diameter; (4) both skin discolorationand uneven texture easily noticeable. Slight scaliness. Skin rough tothe touch in some areas; and (1) uneven skin coloration and texture.Numerous areas of scaliness and discoloration, either hypopigmented,erythremic or dark spots. Large areas of uneven color more than 1 cm indiameter. Evaluations were made independently by two clinicians andaveraged.

Clinical grading of skin smoothness can be analyzed via a ten pointanalog numerical scale: (10) smooth, skin is moist and glistening, noresistance upon dragging finger across surface; (7) somewhat smooth,slight resistance; (4) rough, visibly altered, friction upon rubbing;and (1) rough, flaky, uneven surface. Evaluations were madeindependently by two clinicians and averaged.

Skin smoothness and wrinkle reduction can also be assessed visually byusing the methods disclosed in Packman et al. (1978). For example, ateach subject visit, the depth, shallowness and the total number ofsuperficial facial lines (SFLs) of each subject can be carefully scoredand recorded. A numerical score was obtained by multiplying a numberfactor times a depth/width/length factor. Scores are obtained for theeye area and mouth area (left and right sides) and added together as thetotal wrinkle score.

Skin firmness can be measured using a Hargens ballistometer, a devicethat evaluates the elasticity and firmness of the skin by dropping asmall body onto the skin and recording its first two rebound peaks. Theballistometry is a small lightweight probe with a relatively blunt tip(4 square mm-contact area) was used. The probe penetrates slightly intothe skin and results in measurements that are dependent upon theproperties of the outer layers of the skin, including the stratumcorneum and outer epidermis and some of the dermal layers.

Skin softness/suppleness can be evaluated using the Gas BearingElectrodynamometer, an instrument that measures the stress/strainproperties of the skin. The viscoelastic properties of skin correlatewith skin moisturization. Measurements can be obtained on thepredetermined site on the cheek area by attaching the probe to the skinsurface with double-stick tape. A force of approximately 3.5 gm can beapplied parallel to the skin surface and the skin displacement isaccurately measured. Skin suppleness can then be calculated and isexpressed as DSR (Dynamic Spring Rate in gm/mm).

The appearance of lines and wrinkles on the skin can be evaluated usingreplicas, which is the impression of the skin's surface. Silicone rubberlike material can be used. The replica can be analyzed by imageanalysis. Changes in the visibility of lines and wrinkles can beobjectively quantified via the taking of silicon replicas form thesubjects' face and analyzing the replicas image using a computer imageanalysis system. Replicas can be taken from the eye area and the neckarea, and photographed with a digital camera using a low angle incidencelighting. The digital images can be analyzed with an image processingprogram and the are of the replicas covered by wrinkles or fine lineswas determined.

The surface contour of the skin can be measured by using theprofilometer/Stylus method. This includes either shining a light ordragging a stylus across the replica surface. The vertical displacementof the stylus can be fed into a computer via a distance transducer, andafter scanning a fixed length of replica a cross-sectional analysis ofskin profile can be generated as a two-dimensional curve. This scan canbe repeated any number of times along a fix axis to generate a simulated3-D picture of the skin. Ten random sections of the replicas using thestylus technique can be obtained and combined to generate averagevalues. The values of interest include Ra which is the arithmetic meanof all roughness (height) values computed by integrating the profileheight relative to the mean profile height. Rt which is the maximumvertical distance between the highest peak and lowest trough, and Rzwhich is the mean peak amplitude minus the mean peak height. Values aregiven as a calibrated value in mm. Equipment should be standardizedprior to each use by scanning metal standards of know values. Ra Valuecan be computed by the following equation: R_(a)=Standardize roughness;l_(m)=the traverse (scan) length; and y=the absolute value of thelocation of the profile relative to the mean profile height (x-axis).

In other non-limiting aspects, the efficacy of the compositions of thepresent invention can be evaluated by using a skin analog, such as, forexample, MELANODERM™. Melanocytes, one of the cells in the skin analog,stain positively when exposed to L-dihydroxyphenyl alanine (L-DOPA), aprecursor of melanin. The skin analog, MELANODERM™, can be treated witha variety of bases containing the compositions and whitening agents ofthe present invention or with the base alone as a control.Alternatively, an untreated sample of the skin analog can be used as acontrol.

All of the compositions and/or methods disclosed and claimed in thisspecification can be made and executed without undue experimentation inlight of the present disclosure. While the compositions and methods ofthis invention have been described in terms of particular embodiments,it will be apparent to those of skill in the art that variations may beapplied to the compositions and/or methods and in the steps or in thesequence of steps of the method described herein without departing fromthe concept, spirit and scope of the invention. More specifically, itwill be apparent that certain agents which are both chemically andphysiologically related may be substituted for the agents describedherein while the same or similar results would be achieved. All suchsimilar substitutes and modifications apparent to those skilled in theart are deemed to be within the spirit, scope and concept of theinvention as defined by the appended claims.

1. A method for treating skin, the method comprising topically applyingto skin in need thereof a composition comprising effective amounts of:(a) Arctium lappa root extract; and (b) Epilobium angustifolium extract,to reduce expression of a pro-inflammatory cytokine of IL-8, IL-2, orTNF-α in the skin.
 2. The method of claim 1, wherein the composition isapplied to inflamed skin.
 3. The method of claim 1, wherein thecomposition is applied to a comedone, a papule, a pustule, or anodulocystic lesion on the skin.
 4. The method of claim 1, wherein thecomposition is applied to a fine line or wrinkle.
 5. The method of claim1, wherein the composition is a cream or a lotion.
 6. The method ofclaim 1, wherein the composition is an emulsion.
 7. The method of claim6, wherein the emulsion is an oil-in-water emulsion.
 8. The method ofclaim 1, wherein the composition comprises ginkgo biloba extract,cucumber extract, and panthenol.
 9. The method of claim 1, wherein thecomposition further comprises: water; butylene glycol or propyleneglycol or a combination thereof; and glycerin.
 10. The method of claim9, wherein the composition further comprises: retinol; dipotassiumglycyrrhizate; hydrogenated lecithin; disodium EDTA; and andphenoxyethanol.